1. WARNINGS AND ADVISORY NOTICES

Note: Please read all the information in this manual before using the Vitalograph copd-6 BT device. A full set of instructions, including cleaning instructions, is available at www.vitalograph.co.uk.

This Vitalograph device is intended to measure lung function for use in clinic with disposable mouthpieces or filters or for patient use at home under medical supervision.

Take care not to block the mouthpiece with the tongue or teeth. A ‘spitting’ action or coughing will give false readings.

If used at home symptoms must take precedence over device measurements*.

Before use, ensure that the batteries do not exceed their shelf life, as indicated on the batteries.

Store in a clean dry place.

*If you suspect that a defect has occurred you should check the Vitalograph copd-6 BT device for operation.

2. MAIN COMPONENTS OF THE VITALOGRAPH COPD-6 BT

A

Flowhead

B

On / Off button

C

Display

D

User buttons

3. WHAT IS THE VITALOGRAPH COPD-6 BT USED FOR?

The Vitalograph copd-6 BT is a device intended for measuring lung function. It can be used by a healthcare professional or assistant as a rapid pre-spirometry test to screen-out at-risk individuals that do not have COPD and indicate those that may be at risk of COPD at the pre-symptomatic stage of the disease. This “screening” or “case selection” for full spirometry examinations may result in earlier medical intervention and facilitate better clinical outcomes.

4. HOW TO USE THE VITALOGRAPH COPD-6 BT

4.1 Entering Subject Data

The subject’s physical data can be entered into the Vitalograph copd-6 BT in order to calculate predicted data.

To enter the subject data, follow these steps:

Turn the device on, .

The age can now be set ( ). This is done by pressing the or button and releasing when the age is reached. The values will increase/decrease in values of 1. If the button is kept depressed, the values will scroll faster. Press the button to set the age.

The height can now be set ( ). This is done by pressing the or button and releasing when the height is reached. The values will increase/decrease in values of 1. If the button is kept depressed, the values will scroll faster. Press the button to set the height.Note: if height values are set below 100, the device assumes height is in inches and that Weight will be in Ibs rather than Kg.

The gender can now be set ( ). This is done by pressing the or button and releasing when the correct gender is showing. (Male ( ); Female ( )) Press the button to set the gender. After gender is selected, the Vitalograph copd-6 BT will go to Test Mode, where the Blow Icon is showing. On some variants, an additional data field comes first (see below).

(This step may be omitted, depending on the variant) The Population Group (on some variants this is Weight instead) can now be set ( ). This is done by pressing the or button and releasing when the desired setting is reached. Press the button to set.

Set No.

Example Population Group

1

NHANES III Caucasian C

2

NHANES III African-American AA

3

NHANES III Hispanic-American HA

4.2 Performing the Test

The subject should sit down when blowing into the device (unless advised otherwise). Insert a new disposable SafeTway mouthpiece into the device.

Turn the device on, (if not already ON). When the device is ready for a test the blow icon shows ( ).

Instruct the subject and demonstrate (using a mouthpiece) as follows:

“Hold your head up, breathe in as deeply as possible, hold the device in front of your mouth”.

“Hold your breath, place the mouthpiece into your mouth, like this, bite the mouthpiece lightly, and seal your lips firmly around it, like this”. I will demonstrate.

“Blow out as HARD, and FAST as you can, like this, until I tell you to stop” (the unit will beep at end of test - after 6 seconds).

“Be careful not to block the mouthpiece with your tongue or teeth. A ‘spitting’ action will give false readings”.

“Now you do it – deep breath in – bite and seal – blast the air out…keep going – keep blowing”

“Well done!” “Now, we need to do that three times. Rest for a while until you are ready to blow again”.

To view the result (the best values in the session), press the button.

The COPD Classification will show on the right hand arrow.

Green is NORMAL, negative for COPD. No need to refer this subject for spirometry.

Any one of the blue zones, I, II, II or IV are not normal. This subject should be referred for spirometry.

The Obstructive Index (OI) shows on the left hand arrow.

0 - Green is normal.

1, 2 or 3 – Yellow, amber or red are not normal. Refer for spirometry, but this is unlikely to be COPD.

Note: If the right hand (COPD) arrow is not green, nor will the left hand (OI) arrow be green.

This is the end of the test, but if desired some test parameters may be viewed.

Following each blow and at the end of the test session, the FEV1 value will be displayed and below that, FEV1 % Predicted results for that blow, or for the best in session if the button has been pressed. Pressing again will toggle between best and last blow.

Pressing the button will show the FEV6 and FEV6 % Predicted results.

Pressing the button again will show the FEV1/FEV6 and FEV1/FEV6 % Predicted results

Press the button for a final time will show the estimated Lung Age ( )

Notes on testing:

During testing, if an exclamation mark ! appears, this means that the last blow was not a good quality blow and the user should blow again. Reasons for poor quality are;

In the event that a test is < 3 seconds duration and has an abrupt end (change in volume is > 25ml in the last second of the test), the value FEV will be displayed instead of FEV6.

If the test subject experiences side effects such as dizziness or fatigue during the test procedure, stop testing until recovered.

5. SENDING TEST RESULTS TO VITALOGRAPH REPORTS

The test session may be transmitted to the Vitalograph Reports Utility on your PC where it can be stored as a PDF file and viewed or printed.

Before you can transmit you must first have the Vitalograph Reports Utility installed and running on your PC. If the ‘Snake V’ icon is showing in your PC System Tray then the utility is running, if not refer to Vitalograph Reports Utility instructions.

Ensure the Vitalograph copd-6 BT device is powered on.

On Vitalograph Reports ensure ‘Vitalograph copd-6’ is selected as the device. Ensure that ‘Connect using Bluetooth’ tick box is ticked.

Click on the ‘Discover Bluetooth Devices’ button. The Vitalograph copd-6 BT device will be found and saved for future use.

There are two ways to print the test results from the copd-6;

When the device is ready for age entry, press and hold the Enter button for approximately 3 seconds for the last saved session. The or arrow buttons can be used to scroll to the report icon ( ). At the report icon screen the user must click Enter to print and then click the “Start” button on the main screen of Vitalograph Reports.

After completing the test session, press the or buttons to scroll to the report icon ( ). At the report icon screen the user must click Enter to print and then click the “Start” button on the main screen of Vitalograph Reports.

On the Vitalograph Reports enter the Subject Demographic details and Comments. Select ‘Continue’ on Vitalograph Reports when you are finished entering the information.

Select a location for the test report on your PC as requested by Vitalograph Reports. A PDF of the test results will appear and will also be stored to the PC.

5.1 Setting the Obstructive Index and COPD Classification Zones

The Vitalograph copd-6 BT Obstructive Index and COPD Classification zones are set by the manufacturer to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) standard and it is unlikely that a user will wish to change this – however if this is required please follow the following instructions:

The colour systems for each zone type are pre-set as follows:

FEV1% Pred.

Obstructive Index

COPD Classification

FEV1/FEV6 Ratio and FEV% Pred.

≥ 80%

0

Not COPD

FEV1/FEV6 > 0.7

Top Boundary

Stage I

FEV1/FEV6 < 0.70 and FEV1 ≥ 80% Pred.

< 80%

1

Middle Boundary

Stage II

FEV1/FEV6 < 0.70 and FEV1 < 80% Pred.

< 50%

2

Bottom Boundary

Stage III

FEV1/FEV6 < 0.70 and FEV1 < 50% Pred.

< 30%

3

Stage IV

FEV1/FEV6 < 0.70 and FEV1 < 30% Pred.

To set the boundary percentage values for both the Obstructive Index and COPD Classification zones together, follow these steps;

Turn the device on, .

When the icon appears, press and hold the and buttons for approximately 3 seconds.

The top boundary can now be set. This is done by pressing the or button and releasing when the value is reached. The values will increase/decrease in values of 1%. If the button is kept depressed, the values will scroll faster.

Press to set the top boundary value.

The middle boundary can now be set. This is done by pressing the or button and releasing when the value is reached. The values will increase/decrease in values of 1%. If the button is kept depressed, the values will scroll faster.

Press to set the middle boundary value.

The bottom boundary can now be set. This is done by pressing the or button and releasing when the value is reached. The values will increase/decrease in values of 1%. If the button is kept depressed, the values will scroll faster.

Press to set the bottom boundary value.

Press . The device will return to the age entry screen.

5.2 Reviewing the Last Session Test Results

The Vitalograph copd-6 BT will always store the last test session, even after the device has powered itself down or has been switched OFF. In order to view the last test session, follow these steps;

Turn the device on, .

When the device is ready for age entry ( ), press the button for approximately 3 seconds. The last test session (best results) data will now show again.

When you have finished reviewing the data, press the OFF button for 3s. OR

Press . The device will return to the age entry screen ready for entering the next test subject’s data.

6. CARE AND CLEANING OF THE VITALOGRAPH COPD-6 BT

6.1 Daily Procedures

A new mouthpiece (either SafeTway or BVF) should be used for each subject. A delay of at least 5 minutes should be allowed between subjects to allow settling of previously aerosolized particles in the measuring device.

6.2 Monthly Procedures

It is recommended that the device be regularly cleaned according to the guidelines of the user’s facility. The disinfection materials and procedures applied in the users’ facility may be more appropriate than the methods outlined below. In the event of visible contamination of the flowhead element, it should be cleaned or disinfected as described in the accompanying table. The device should be replaced in the event of damage, or if visibly contaminated.

The frequency of cleaning and disinfecting is dependent on the facility’s risk assessment, usage, and test environment, but it should be at least monthly or every 100 subjects (300 blows).

6.3 Annual Procedures

It is recommended that the device be replaced annually or test and calibration serviced at least annually. There is no planned preventive maintenance for this medical device.

6.4 Table of Materials Used & Cleaning/Disinfection Methods

This listing of materials used is given to provide clinical users with information to allow the assessment of other cleaning and disinfecting procedures available in the facility on this device.

Part

Material

Clean/ Disinfect

Autoclave Possible?

Recommended Disinfectants

SafeTway mouthpiece or BVF

Cardboard / ABS

Dispose – single use

No

Dispose – single use

Case Exterior

PC/ABS

Clean

No

Wiping with a 70% isopropyl alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection. This may be preceded by cleaning with an anti-static foam cleaner if necessary.

Fascia

PMMA/PET

Clean

No

Removable Flowhead

PC/ABS

Clean

No

Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes (see following section for recommended cleaning/disinfection method for the flowhead)

Maximum of 50 cleaning cycles allowed.

All external parts of the Vitalograph copd-6 require cleaning, i.e. the removal of visible particulate contamination. The parts of the device that make up the flowhead, which comes into contact with the breath of the subjects being tested, also require disinfecting. This device is not designated as a ‘sterile’ device.

6.5 Removing the Flowhead for Cleaning and Disinfecting

Flowhead Disassembled

Flowhead Assembled

Remove the flowhead from the body with a sharp pulling motion.

Clean the flowhead by washing in a mild detergent to remove particulate contamination, taking care not to touch the moving vanes. Swill vigorously in water with mild detergent. Do not attempt to “rub” or “scrub” in the area of the vanes. Rinse with clean water.

Disinfect by immersion in sodium dichloroisocyanurate solution at 1000 ppm concentration of free chlorine for 15 minutes. Prepare disinfectant solution as directed in the manufacturer’s guidelines. Rinse with warm water for faster drying.

Leave it to dry completely before reassembling. Drying the flowhead may require placing it in a warm place overnight. A drying cabinet is ideal.

Wiping with a 70% Isopropyl Alcohol impregnated cloth provides a suitable form of cleaning and low-level disinfection for the case exterior, display, screen surround and keys. Repeat this at least weekly to prevent a build-up of grime from normal handling and use. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals or equipment.

Reassemble the flowhead by pushing back on until it ‘clicks’ into position. Ensure that the flowhead is pushed fully home.

Definitions of cleaning and disinfection are as defined in “Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Committee to Department of Health Medical Devices Directorate, 1996”

Recommendations for chemical disinfectants are derived from the PHLS publication “Chemical Disinfection in Hospitals 1993"

7. Consumables,
Accessories and spare parts

Cat. no

Description

20242

SafeTway Mouthpieces (200)

20303

Disposable Noseclips (200)

20980

Safetway Mouthpieces mini (50)

20991

Safetway Mouthpieces long (130)

28350

BVF (50)

40167

Pouch Spare (x10)

8. Explanation of Symbols

Type BF equipment

Class II

The device must be taken to separate collection at the
product end-of-life. Do not dispose of these products as unsorted
municipal waste.

10. CE Notice

Marking by the symbol compliance
of the Vitalograph 4000 Respiratory Monitor copd-6 device to the Medical Devices Directive of the European Community. Such marking is indicative that the Vitalograph 4000 Respiratory Monitor copd-6 device meets or exceeds the following technical standards:

Guidance and manufacturer’s declaration – electromagnetic emissions

The 4000 Respiratory Monitor copd-6 is intended for use in the electromagnetic environment specified below. The customer or the user of 4000 Respiratory Monitor copd-6 should assure that it is used in such an environment.

Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions CISPR 11

Group 1

The 4000Respiratory Monitor copd-6 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The 4000Respiratory Monitor copd-6 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions
IEC 61000-3-2

Class A

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Class A

Guidance and manufacturer’s declaration – electromagnetic immunity

The 4000Respiratory Monitor copd-6 is intended for use in the electromagnetic environment specified below. The customer or the user of the 4000Respiratory Monitor copd-6 should assure that it is used in such an environment.

Immunity test

IEC 60601 Test level

Compliance level

Electromagnetic environment- guidance

Electrostatic discharge (ESD)
IEC 61000-4-2

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines
±1 kV for input/ output lines

Battery operated device

Surge
IEC 61000-4-5

±1kV differential mode
±2kV common mode

Battery operated device

Voltage dips, short interruptions and voltage variations on power supply input lines

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Guidance and manufacturer’s declaration – electromagnetic immunity

The 4000Respiratory Monitor copd-6 is intended for use in the electromagnetic environment specified below. The customer or the user of the 4000Respiratory Monitor copd-6 should assure that it is used in such an environment.

Immunity test

IEC 60601 Test level

Compliance level

Electromagnetic environment - guidance

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

10 Vrms
150kHz to 80 MHz in ISM bands

3 V/m
80 MHz to 2,5 GHz

Battery operated device

3V/m from 80MHz to 2.5 GHz

Portable and mobile RF communications equipment should be used no closer to any part of the 4000 Respiratory Monitor asma-1 including cables, than the recommended separation distance calculated form the equation applicable to the frequency of the transmitter.

Recommended separation distance

d=0.35√P

d=0.35√P 80MHz to 800MHzd=0.7√P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

The 4000Respiratory Monitor copd-6 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the 4000Respiratory Monitor copd-6 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 4000Respiratory Monitor copd-6 as recommended below, according to the maximum output power of the communications equipment.

Rated maximumoutput power oftransmitter

W

Separation distance according to frequency of transmitter (m)

150 kHz to 80 MHzd = 1.2 √P

80 MHz to 800 MHzd = 1.2√P

800 MHz to 2.5GHzd = 2.3√P

0.01

0.1m

0.1m

0.2m

0.1

0.4m

0.4m

0.7m

1

1.2m

1.2m

2.3m

10

3.7m

3.7m

7.4m

100

11.7m

11.7m

23.3m

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Medical Devices may be affected by cellular telephones and
other
personal or household devices not intended for medical facilities. It
is recommended that all equipment used near the Vitalograph product
comply with the medical electromagnetic compatibility standard and to
check before use that no interference is evident or possible. If
interference is suspected or possible, switching off the offending
device is the normal solution, as is required in aircraft and medical
facilities.

Medical electrical equipment needs special precautions
regarding
EMC and needs to be installed and put into service according to the EMC
information provided.

11. FDA Notice

Caution: Federal Law restricts this device to sale by, or
on
the order of a physician.

12. Declaration of
Conformity

Product: 4000 Respiratory Monitor copd-6

Vitalograph hereby ensures and declares that the above product associated with this user manual, is designed and manufactured in accordance with the following QMS regulations and standards:

European Medical Devices Directive {MDD} 93/42/EEC

This device, classified as 2a as per Annex IX of MDD 93/42/EEC, meets the following provisions of Annex II of the Medical Devices Directive as per Article 11, section 3a, excluding point 4 of Annex II.
This device complies with the EMC Directive 89/336/EC, conformance demonstrated by following standard EN60601-1-2:2001. Equipment classification: Residential.

13. Guarantee

Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its opinion replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials.

The conditions of this Guarantee are:

This Guarantee shall only apply to hardware defects which are notified to the Company or to its accredited distributor within 1 year of the date of purchase of the equipment, unless otherwise agreed in writing by the Company

Software (meaning computer software, or user installable modules) is guaranteed for 90 days from the date of purchase.

The Company warrants that the software when correctly used in conjunction with the hardware will perform in the manner described in the Company's literature and user manuals. The Company undertakes to rectify at no expense to the customer any software failure notified within the period stated above, provided that the failure can be recreated and the software has been installed and used in accordance with the user manual. Notwithstanding this clause, the software is not warranted to be free of errors.

This Guarantee does not cover any faults caused by accident, misuse, neglect, tampering with the equipment, use of consumable items or parts not approved by the Company, or any attempt at adjustment or repair other than by personnel accredited by the Company, nor does it cover reinstatement of any configuration changes caused by the installation of any software.

If a defect occurs, please contact the supplier from whom it was purchased for advice. The Company does not authorise any person to create for it any other obligation or liability in connection with VitalographÒ equipment

This Guarantee is not transferable and no person, firm or company has any authority to vary the terms or conditions of this Guarantee.

To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph® equipment.

This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.